Clinical Application of Partial and Total Ossicular Replacement Prostheses of Hydroxyapatite Based Scaffolds Cultured with Human Mesenchymal Stromal Cells

Objective: To evaluate the feasibility of hydroxyapatite PORP and TORP as a scaffold with human mesenchymal stromal cells (hMSCs) and their use as replacement prosthesis during ossiculoplasty.Study Design: Application of tissue engineering in a prospective clinical study.Subjects and Methods: This study was conducted in 8 patients (6 canal wall down and 2intact canal wall tympanomastoidectomy) between April 2008 and June 2009.Prosthesis Preparation: In all the cases, 2 days before transplantation, hydroxyapatite implants were loaded by the cells obtained from culture obtained from patients’ own bone marrow. The cell suspension was applied to seed on scaffolds placed in 12-well tissue culture plates at a density of 2×106cells/scaffold. All pre and post operative audiometric evaluations (pure tone air and bone conduction thresholds) were carried out in the same center and by the same audiologist before and 3 months, 6 months , and one year after the operation.Setting: Otolaryngology, head and neck surgery department in a tertiary academic medical center.Results: The hMSCs were positive for CD10, CD44, CD166, CD106, HLA-ABC, CD90, CD54, and CD105, but were negative for CD34, CD45, CD117, and CD31. Mean air-bone gap closure was 19.57 dB. There was no sign of prosthesis extrusion at the end of twelve month follow-up period in all cases.Conclusion: The idea of tissue-engineered ear ossicles is a feasible and interesting option for the replacement of the ear ossicles. However, the final outcome needs longer follow-ups